Surgical image-guided navigation devices and related systems

ABSTRACT

MRI compatible localization and/or guidance systems for facilitating placement of an interventional therapy and/or device in vivo include: (a) a mount adapted for fixation to a patient; (b) a targeting cannula with a lumen configured to attach to the mount so as to be able to controllably translate in at least three dimensions; and (c) an elongate probe configured to snugly slidably advance and retract in the targeting cannula lumen, the elongate probe comprising at least one of a stimulation or recording electrode. In operation, the targeting cannula can be aligned with a first trajectory and positionally adjusted to provide a desired internal access path to a target location with a corresponding trajectory for the elongate probe. Automated systems for determining an MR scan plane associated with a trajectory and for determining mount adjustments are also described.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/693,456, filed Apr. 22, 2015, which is a continuation of U.S. patentapplication Ser. No. 12/066,862, with an international filing date Nov.29, 2006 (with a national phase filing date of Aug. 29, 2008), which isnow U.S. Pat. No. 9,042,958, issued May 26, 2015, which is a 35 USC 371national phase application of PCT/US2006/045752, filed Nov. 29, 2006,which claims the benefit of U.S. Provisional Patent Application Ser. No.60/740,353, filed Nov. 29, 2005, the contents of which are herebyincorporated by reference as if recited in full herein.

FIELD OF THE INVENTION

The present invention relates to placement/localization ofinterventional medical devices and/or therapies in the body. Embodimentsof the present invention may be particularly suitable for placingneuro-modulation leads, such as Deep Brain Stimulation (“DBS”) leads,implantable parasympathetic or sympathetic nerve chain leads and/or CNSstimulation leads.

BACKGROUND OF THE INVENTION

Deep Brain Stimulation (DBS) is becoming an acceptable therapeuticmodality in neurosurgical treatment of patients suffering from chronicpain, Parkinson's disease or seizure, and other medical conditions.Other electro-stimulation therapies have also been carried out orproposed using internal stimulation of the sympathetic nerve chainand/or spinal cord, etc.

One example of a prior art DBS system is the Activa® system fromMedtronic, Inc. The Activa® system includes an implantable pulsegenerator stimulator that is positioned in the chest cavity of thepatient and a lead with axially spaced apart electrodes that isimplanted with the electrodes disposed in neural tissue. The lead istunneled subsurface from the brain to the chest cavity connecting theelectrodes with the pulse generator. These leads can have multipleexposed electrodes at the distal end that are connected to conductorswhich run along the length of the lead and connect to the pulsegenerator placed in the chest cavity.

MRI is an imaging modality that can be used to evaluate cardiac,neurological and/or other disorders. It may be desirable to use MRI forpatients with implanted stimulation devices and leads. However,currently available lead systems may be unsuitable to use in a magneticresonance imaging (MRI) environment. For example, the devices may not beMRI compatible, i.e., they may contain ferromagnetic materials, whichmay distort the MRI images. Also, currently available lead/probe/cablesystems may be susceptible to unwanted induced RF and/or AC currentand/or localized heating of the tissue. For example, the MedtronicActiva® device typically recommends that MRI imaging be carried out in a1.5T magnet without using body coils, i.e., only using head coils fortransmission of the RF excitation pulse(s). Also, the problem ofunwanted RF deposition may increase as higher magnetic fields, such as3T systems, become more common for MRI imaging (the RF pulses havingshorter wavelengths).

It is believed that the clinical outcome of certain medical procedures,particularly those using DBS, may depend on the precise location of theelectrodes that are in contact with the tissue of interest. For example,to treat Parkinson's tremor, presently the DBS probes are placed inneural tissue with the electrodes transmitting a signal to the thalamusregion of the brain. DBS stimulation leads are conventionally implantedduring a stereotactic surgery, based on pre-operative MRI and CT images.These procedures can be long in duration and may have reduced efficacyas it has been reported that, in about 30% of the patients implantedwith these devices, the clinical efficacy of the device/procedure isless than optimum.

Notwithstanding the above, there remains a need for alternativeinterventional tools.

SUMMARY OF EMBODIMENTS OF THE INVENTION

Embodiments of the present invention are directed to medical tools,systems and methods useful for MRI-guided localization and/or placementof interventional therapies and/or devices.

Some embodiments of the present invention provide systems that utilizeat least one MRI to visualize (and/or locate) a therapeutic region ofinterest (such as, for example, a target site inside the brain) andutilize at least one MRI to visualize (and/or locate) an interventionaltool or tools that are used to deliver a therapy and/or to place achronically (typically permanently) implantable device that will delivera therapy.

Some embodiments include a targeting cannula with a lumen sized andconfigured to slidably receive an elongate probe. The elongate probe caninclude a recording electrode (e.g., transducer) and/or a stimulationelectrode. Optionally, the targeting cannula and/or probe or componentsthereof may be MRI visible.

Some embodiments of the present invention can be used to placeinterventional lead systems in the body. The lead placement systems canbe configured to both collect MRI and/or NMR data and sense localsignals (e.g., EEG signals) and may also or alternatively be configuredto stimulate local (e.g., neural) tissue. The lead placement system maybe used to place implantable deep brain stimulation leads. The leadplacement systems may also be configured to place implantable cardiacinterventional leads or devices.

The lead placement system can include a probe and/or sheath that can berelatively long, having a length in the body of greater than 10 cm, ormay have a lesser length, such as between about 3-6 cm. The probe and/orlead can hold one or a plurality of electrodes and/or at least one maybe a recording electrode. The probe may hold a recording and astimulating electrode. The probe and/or sheath can be MRI active(include MRI imaging coils and/or cooperate with other components todefine an MRI antenna).

In some embodiments, the electrodes and stimulation control module canbe configured to generate different stimulation field patterns havingdifferent size and shape stimulation volumes and different directionalstimulation volumes and the patient data analysis module may beconfigured to automatically determine an optimal location of anelectrode for DBS for a particular patient.

Still other embodiments are directed to systems for MRI guided placementof deep brain stimulation leads. The systems include a translatabletargeting cannula, a frameless mount configured to hold the targetingcannula, and an MRI antenna with transducer configured to releasablyengage the targeting cannula. The cannula may be configured to beinserted into a burr hole placed in a patient's skull and thestimulation probe and MRI antenna and stimulation probe may beconfigured for deep brain placement guided through the cannula.

Some embodiments are directed to MRI compatible localization and/orguidance systems for facilitating placement of an interventional devicein vivo. The systems include: (a) a mount having a base with a patientaccess aperture adapted for fixation to a patient, wherein an upperportion of the mount is able to controllably translate with at least twodegrees of freedom; (b) a targeting cannula having at least one axiallyextending lumen configured to attach to the mount; and (c) an elongateprobe configured to snugly slidably advance and retract in one of the atleast one axially extending lumen of the targeting cannula, the elongateprobe comprising at least one of a recording electrode or a stimulationelectrode. In operation, the mount can be adjusted to provide a desiredinternal access path trajectory to a target location.

Some embodiments are directed to MRI compatible localization and/orguidance systems for facilitating placement of an interventional devicein vivo. The systems include: (a) a mount having a receiving port and abase with an access aperture adapted for fixation to a patient, themount port configured to translate with at least two degrees of freedom;(b) a targeting cannula having at least one axially extending lumenconfigured to reside in the port; and (c) an elongate probe configuredto define an MRI antenna configured to snugly slidably advance andretract in one of the at least one axially extending lumen of thetargeting cannula. In operation, the targeting cannula can bepositionally adjusted in the mount to provide a desired internal accesspath trajectory through the mount access aperture to a target location.

Some embodiments are directed to MRI interventional tools that include:(a) a cannula with a through lumen and at least one axially extendingclosed fluid filled lumen or channel; and (b) a first multipurpose probeconfigured to slidably extend through the lumen of the cannula.

Some embodiments are directed to MRI-compatible interventional toolsthat include: (a) a frameless mount; (b) a multi-lumen insert configuredto mount to the frameless mount; and (c) an MRI visible targetingcannula with a closed perimeter configured to slidably reside in onelumen of the multilumen insert when the insert is mounted to theframeless mount.

Other embodiments are directed to MRI interventional or placement toolsthat include: (a) a mount having a patient access aperture configured tomount to a patient; (b) an elongate delivery sheath extendable fromthrough the access aperture of the mount to a target access location inthe patient; and (c) a fluid filled tube configured to slidably advancewith and retract from the sheath.

Still other embodiments are directed to MRI guided localization systems.The systems include: (a) a base with an in vivo access apertureconfigured to mount to a patient; (b) a translatable mount memberattached to the base, the translatable member configured to translateabout a pivot point extending proximate the base access aperture, thetranslatable member having a receiving port configured to receive atleast one of a targeting cannula or a multi-lumen insert; (c) aplurality of sensors in communication with at least one of the base andtranslatable member whereby the sensors define positional data of themount member; (d) a drive system in communication with the translatablemount member; and (e) a control circuit in communication with the drivesystem configured to direct the translatable member to translate todefine a desired trajectory orientation.

Some embodiments are directed to automated trajectory adjustmentsystems. The systems include: (a) a mount member with a base having anaccess aperture therethrough configured to reside against a mountingsurface of a patient; (b) an MRI visible elongate member configured tomount to the mount member; (c) at least one position sensor incommunication with the mount member; (d) a drive system in communicationwith the mount member; and (e) a control circuit in communication withthe drive system configured to identify adjustments to alter theposition of the mount member to obtain a desired trajectory of an accesspath through the access aperture into the patient.

Other embodiments are directed to systems for MRI guided localization oftherapies/tools. The systems include: (a) an MRI visible elongatemember; and (b) a localization system in communication with a MRIscanner configured to programmatically determine a scan plane locationof the elongate member having a first trajectory in 3D MRI space wherebythe elongate member acts as an MRI detectable marker.

Still other embodiments are directed to methods for automaticallydefining a scan plane associated with an elongate MRI visible marker.The methods include programmatically determining a scan plane locationof an MRI visible elongate member held in a mount affixed to a patientand residing in 3D MRI space with an associated first trajectory.

Some embodiments are directed to frameless head mounts for MRIinterventional procedures. The mounts include: (a) a base having apatient access aperture configured to affix to a burr hole in a skull ofa patient; (b) a rotatable platform attached to the base; and (c) a pairof spaced apart upwardly extending arms holding a receiving port, thereceiving port being able to translate in response to translation of thearms.

The frameless mount may optionally also include respectivenon-ferromagnetic flexible drive cables attached to the rotation andpitch adjustment members to allow a user to adjust an access pathtrajectory while the user resides proximate but outside an end of a boreof a magnet associated with an MRI scanner without moving the patient.The mount may also optionally include an automated trajectory adjustmentcircuit in communication with the adjustment members whereby thereceiving port is automatically moved to a desired position based on MRIdata.

Another aspect of the invention relates to methods of adjusting atrajectory of a head mount defining an internal access path trajectoryduring an MRI-guided interventional procedure. The method includes: (a)affixing a head mount with a holding member having adjustable pitch androtation to a head of a patient; and (b) adjusting at least one of pitchor rotation of the holding member to define a desired access pathtrajectory into the patient while the patient remains in position in abore of a magnet.

Although described above with respect to method aspects of the presentinvention, it will be understood that the present invention may also beembodied as systems and computer program products.

Other systems, methods, and/or computer program products according toembodiments of the invention will be or become apparent to one withskill in the art upon review of the following drawings and detaileddescription. It is intended that all such additional systems, methods,and/or computer program products be included within this description, bewithin the scope of the present invention, and be protected by theaccompanying claims.

These and other embodiments will be described further below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic illustration of a MRI guided localization systemaccording to embodiments of the present invention.

FIG. 1B is a schematic partial side view illustration of a targetingcannula and probe according to some embodiments of the invention.

FIG. 1C is a partial side view illustration of a different targetingcannula configuration and a different probe configuration according toembodiments of the invention.

FIG. 2A is a partial side view illustration of a device with aretractable sheath according to embodiments of the invention.

FIG. 2B a partial side view illustration of the device shown in FIG. 2Aillustrating the sheath remaining in position as the probe is retractedaccording to embodiments of the invention.

FIG. 2C is a schematic partial top view of a probe and sheath shown inFIG. 2A illustrating visual indicia of movement according to embodimentsof the present invention.

FIG. 2D is a sectional view of the probe and sheath shown in FIG. 2Caccording to embodiments of the present invention.

FIG. 2E is a side view of the sheath acting as a targeting cannula incombination with a fluid filled or MRI visible tube according to someembodiments of the invention.

FIG. 3A is a side view of a stimulation lead according to embodiments ofthe present invention.

FIG. 3B is a section view of the device shown in FIG. 3A, taken alongline 3B-3B.

FIG. 3C is an electrical schematic diagram of the device shown in FIG.3A according to embodiments of the present invention.

FIG. 4A is a schematic illustration of a long lead with a plurality ofaxially spaced apart RF traps along a length of a conductor or leadaccording to embodiments of the invention.

FIG. 4B is a schematic illustration of a lead system with RF trapshaving co-wound conductors in a common shield according to embodimentsof the invention.

FIG. 5 is a block diagram of a bimodal lead operating circuit accordingto embodiments of the present invention.

FIG. 6 is a block diagram of another operating circuit according toembodiments of the present invention.

FIG. 7A is a schematic illustration of a splitter circuit according toembodiments of the present invention.

FIG. 7B is an end view of the circuit shown in FIG. 7A.

FIG. 8 is a schematic illustration of a localization system according toembodiments of the invention.

FIG. 9 is a flow chart of operations that can be used to carry outembodiments of the invention.

FIG. 10A is a greatly enlarged side view of a frameless mount accordingto embodiments of the invention.

FIG. 10B is a greatly enlarged side view of a frameless mount similar tothat shown in FIG. 10A, illustrating pitch and rotation adjustmentmembers according to embodiments of the invention.

FIG. 10C is a greatly enlarged front perspective view of the deviceshown in FIG. 10B.

FIG. 10D is a greatly enlarged side perspective view of the device shownin FIG. 10B.

FIG. 10E is a greatly enlarged front view of a different configurationof the device shown in FIG. 10B according to embodiments of theinvention.

FIGS. 11A-11F illustrate different configurations of the frameless mountshown in FIG. 10A.

FIG. 12A is a perspective side view of a multi-lumen insert that can beheld by a mount according to embodiments of the invention.

FIG. 12B is a side view, FIGS. 12C and 12D are end views and FIG. 12E isa side view (with the top facing down) of the device shown in FIG. 12A.

FIG. 13A is a side perspective view of the mount shown in FIG. 12A withthe multi-lumen insert shown in FIG. 12A according to some embodimentsof the invention. FIGS. 13B and 13C are side and front views thereof.

FIG. 14 is a partially transparent side view of a targeting cannula witha through lumen and a fluid filled axially extending segment accordingto embodiments of the invention.

FIG. 15A is a schematic side view of a targeting cannula with a fluidfilled chamber that can reside in a lumen of a multi-lumen insert suchas that shown in FIG. 12A.

FIG. 15B is a side schematic view of the targeting cannula shown in FIG.15A alternately configured with an axially extending side arm accordingto some embodiments of the invention.

FIG. 16A is a schematic illustration of a visualization of trajectorylines in an oblique coronal/sagittal image extending from differentlumens to a target site according to some embodiments of the invention.

FIG. 16B is a schematic illustration of the trajectory lines as theyintersect the target site in an axial/oblique scan according toembodiments of the invention.

FIGS. 17A-17C are schematic illustrations of steps that can be taken toplace a site-specific interventional device or therapy according to someembodiments of the invention.

FIGS. 18A-18E are schematic illustration of additional steps that can betaken to define a trajectory and/or place an interventional deviceaccording to embodiments of the invention.

FIGS. 19 and 20 are block diagrams of data processing systems accordingto embodiments of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention will now be described more fully hereinafter withreference to the accompanying drawings, in which embodiments of theinvention are shown. This invention may, however, be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art. Likenumbers refer to like elements throughout. It will be appreciated thatalthough discussed with respect to a certain antenna embodiment,features or operation of one lead system embodiment can apply to others.

In the drawings, the thickness of lines, layers, features, componentsand/or regions may be exaggerated for clarity and broken linesillustrate optional features or operations, unless specified otherwise.In addition, the sequence of operations (or steps) is not limited to theorder presented in the claims unless specifically indicated otherwise.It will be understood that when a feature, such as a layer, region orsubstrate, is referred to as being “on” another feature or element, itcan be directly on the other element or intervening elements may also bepresent. In contrast, when an element is referred to as being “directlyon” another feature or element, there are no intervening elementspresent. It will also be understood that, when a feature or element isreferred to as being “connected” or “coupled” to another feature orelement, it can be directly connected to the other element orintervening elements may be present. In contrast, when a feature orelement is referred to as being “directly connected” or “directlycoupled” to another element, there are no intervening elements present.Although described or shown with respect to one embodiment, the featuresso described or shown can apply to other embodiments.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items. As used herein, phrases such as “between X and Y” and“between about X and Y” should be interpreted to include X and Y. Asused herein, phrases such as “between about X and Y” mean “between aboutX and about Y.” As used herein, phrases such as “from about X to Y” mean“from about X to about Y.”

The term “RF safe” means that the device, lead or probe is configured tooperate safely when exposed to normal RF signals associated withconventional MRI systems. The device can be configured with RF chokes,RF traps, high impedance segments and/or other electrical circuits thatallow for the RF safe operation in MRI environments. The device may beactive or decoupled during RF transmit in an MRI procedure.

The term “MRI visible” means that the device is visible, directly orindirectly, in an MRI image. The visibility may be indicated by theincreased SNR of the MRI signal proximate to the device (the device canact as an MRI receive antenna to collect signal from local tissue)and/or that the device actually generates MRI signal itself, such as viasuitable hydro-based coatings and/or fluid (typically aqueous solutions)filled channels or lumens. The term “MRI compatible” means that theso-called system and/or component(s) is safe for use in an MRIenvironment and/or can operate as intended in an MRI environment, and,as such, if residing within the high-field strength region of themagnetic field, is typically made of a non-ferromagnetic MRI compatiblematerial(s) suitable to reside and/or operate in a high magnetic fieldenvironment. The term high-magnetic field refers to field strengthsabove about 0.5 T, typically above 1.0T, and more typically betweenabout 1.5T and 10T.

The term “targeting cannula” refers to an elongate device, typicallyhaving a substantially tubular body that can be oriented to providepositional data relevant to a target treatment site and/or define adesired access path orientation or trajectory. At least portions of thetargeting cannulae contemplated by embodiments of the invention can beconfigured to be visible in an MRI image, thereby allowing a clinicianto visualize the location and orientation of the targeting cannula invivo relative to fiducial and/or internal tissue landscape features.Thus, the term “cannula” refers to an elongate device that can beinserted into a mount that attaches to a patient, but does notnecessarily enter the body of a patient.

The term “imaging coils” refers to a device that is configured tooperate as an MRI receive antenna. The term “coil” with respect toimaging coils is not limited to a coil shape but is used generically torefer to MR′ antenna configurations, loopless, looped, etc., as areknown to those of skill in the art. The term “fluid-filled” means thatthe component includes an amount of the fluid but does not require thatthe fluid totally, or even substantially, fill the component or a spaceassociated with the component. The fluid may be an aqueous solution, MRcontrast agent, or any material that generates MRI signal.

The term “two degrees of freedom” means that the mount allows for atleast translational (swivel or tilt) and rotational movement over afixed site, which may be referred to as a Remote Center of Motion (RCM).

The term “interactive” refers to a device and/or algorithm that canrespond to user input to provide an output, typically using a GraphicUser Interface (GUI). The GUI may operate with known GUI drawing tools,such as spline inputs to define a target treatment site and/ortrajectory to the site in an image of an MRI visualization of thepatient on a clinician workstation display. The term “spline” refers tofree-form curves defined with a set of control points. Drawing of aspline curve is by placement of these points. An open or closed splinecan be selected using a spline dialog. An object or point can be movedby holding down an input key, such as <Shift>. The control points can beedited using a point editing mode where a handle to move the controlpoint. For example, holding down <Control> and dragging on a handle toalter the shape factor of that control point.

The term “programmatically” refers to operations directed and/orprimarily carried out electronically by computer program modules, codeand instructions.

The term “high radiofrequency” or “high RF” refers to RF frequenciesthat are at or above about 1 MHz, and includes radiofrequencies in therange of about 1 MHz to about 256 MHz. Some embodiments of the presentinvention configure devices so as to have high impedance circuitsegments or a high impedance circuit at high RF and low impedancecircuit segments or circuit at DC or low frequency (at a kHz or lessfrequency or frequency range), i.e., at frequencies used for treatmentsuch as stimulation or ablation. For example, for 1.5T, 3.0T and 6.0Tsystems, the respective frequencies are 64 MHz, 128 MHz and 256 MHz. Thefrequencies of the different MRI systems are well known to those ofskill in the art. The devices can be configured to have high impedanceat several of the radiofrequencies associated with high-field magnet MRIsystems, such as systems with magnets above about 1.0T, such as about1.0T, 1.5T, 2.0T, 3.0T, 4.0T, 5.0T, 6.0T and 9.0T, typically betweenabout 1T to 15T.

The term “high impedance” means an impedance sufficiently high toinhibit, block or eliminate flow of RF-induced current at a targetfrequency range(s). The impedance has an associated resistance andreactance as is well known to those of skill in the art. Someembodiments provide an impedance of at least about 300 Ohms, typicallybetween about 400 Ohms to about 600 Ohms, such as between about 450 Ohmsto about 500 Ohms, while other embodiments provide an impedance ofbetween about 500 Ohms to about 1000 Ohms. Embodiments of the inventionconfigure lead systems that provide sufficiently high-impedance atfrequencies associated with a plurality of different conventional andfuture magnetic field strengths of MRI systems, such as at least two of1.5T, 2.0T, 2.5T, 3.0T, 9.0T, and the like, allow for safe use in thoseenvironments (future and reverse standard MRI system compatibility).

The term “tuned” means that a parallel resonant circuit with inductiveand capacitive characteristics defined by certain components andconfigurations has high impedance at one or more target frequencies,typically including one or more MRI operating frequencies.

The term “coiled segment” refers to a conductive lead (trace, wire orfilar) that has a coiled configuration. The term “co-wound segments”means that the affected leads, conductors, wires and/or filars can besubstantially concentrically coiled at different radii, one above theother, or concentrically coiled closely spaced at substantially the samediameter. The term “co-wound” is used to describe structure and is notlimiting to how the structure is formed (i.e., the coiled segments arenot required to be wound concurrently or together, but may be soformed). The terms “conductive element”, “conductive lead” and“conductors” are used interchangeably and refer to a conductive paththat connects target components (such as, for example, a stimulationsource and an electrode) and can include one or combinations of ametallic trace, a wire, a flex circuit, a filar(s), or other conductiveconfiguration. As such, the conductors or conductive elements includelong linear and/or non-linear conductors that can be formed with one ormore of discrete wires, flex circuits, filars (bi, quadra or otherwinding), or by plating, etching, deposition, or other fabricationmethods for forming conductive electrical paths.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art andthis application and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein.

Embodiments of the present invention can be configured to guide and/orplace interventional devices and/or therapies to any desired internalregion of the body or object. The object can be any object, and may beparticularly suitable for animal and/or human subjects. Some probeembodiments can be sized and configured to place implantable DBS leadsfor brain stimulation, typically deep brain stimulation. Someembodiments can be configured to deliver tools or therapies thatstimulate a desired region of the sympathetic nerve chain. Other usesinside or outside the brain include stem cell placement, gene therapy ordrug delivery for treating physiological conditions. Some embodimentscan be used to treat tumors.

In some embodiments the interventional tools can be configured tofacilitate high resolution imaging via integral imaging coils (receiveantennas), and/or the interventional tools can be configured tostimulate local tissue, which can facilitate confirmation of properlocation by generating a physiologic feedback (observed physicalreaction or via fMRI).

Some embodiments can be used to deliver bions, stem cells or othertarget cells to site-specific regions in the body, such as neurologicaltarget and the like. In some embodiments, the systems deliver stem cellsand/or other cardio-rebuilding cells or products into cardiac tissue,such as a heart wall via a minimally-invasive MRI guided procedure,while the heart is beating (i.e., not requiring a non-beating heart withthe patient on a heart-lung machine). Examples of known stimulationtreatments and/or target body regions are described in U.S. Pat. Nos.6,708,064; 6,438,423; 6,356,786; 6,526,318; 6,405,079; 6,167,311;6,539,263; 6,609,030 and 6,050,992, the contents of which are herebyincorporated by reference as if recited in full herein.

Generally stated, some embodiments of the invention are directed to MRIinterventional procedures and provide interventional tools and/ortherapies that may be used to locally place interventional tools ortherapies in vivo to site specific regions using an MRI system. Theinterventional tools can be used to define an MRI-guided trajectory oraccess path to an in vivo treatment site. Some embodiments of theinvention provide interventional tools that can provide positional dataregarding location and orientation of a tool in 3-D space with a visualconfirmation on an MRI. Embodiments of the invention may provide anintegrated system that may allow physicians to place interventionaldevices/leads and/or therapies accurately and in shorter durationprocedures over conventional systems (typically under six hours for DBSimplantation procedures, such as between about 1-5 hours).

In some embodiments, an MRI can be used to visualize (and/or locate) atherapeutic region of interest inside the brain and utilize an MRI tovisualize (and/or locate) an interventional tool or tools that will beused to deliver therapy and/or to place a permanently implanted devicethat will deliver therapy. Then, using the three-dimensional dataproduced by the MRI system regarding the location of the therapeuticregion of interest and the location of the interventional tool, thesystem and/or physician can make positional adjustments to theinterventional tool so as to align the trajectory of the interventionaltool, so that when inserted into the body, the interventional tool willintersect with the therapeutic region of interest. With theinterventional tool now aligned with the therapeutic region of interest,an interventional probe can be advanced, such as through an open lumeninside of the interventional tool, so that the interventional probefollows the trajectory of the interventional tool and proceeds to thetherapeutic region of interest. It should be noted that theinterventional tool and the interventional probe may be part of the samecomponent or structure. A sheath may optionally form the interventionaltool or be used with an interventional probe or tool.

In particular embodiments, using the MRI in combination with imagingcoils and/or MRI contrast material that may be contained at leastpartially in and/or on the interventional probe or sheath, the locationof the interventional probe within the therapeutic region of interestcan be visualized on a display or image and allow the physician toeither confirm that the probe is properly placed for delivery of thetherapy (and/or placement of the implantable device that will deliverthe therapy) or determine that the probe is in the incorrect or anon-optimal location. Assuming that the interventional probe is in theproper desired location, the therapy can be delivered and/or theinterventional probe can be removed and replaced with a permanentlyimplanted therapeutic device at the same location.

In some embodiments, in the event that the physician determines from theMRI image produced by the MRI and the imaging coils, which mayoptionally be contained in or on the interventional probe, that theinterventional probe is not in the proper location, a new therapeutictarget region can be determined from the MRI images, and the system canbe updated to note the coordinates of the new target region. Theinterventional probe is typically removed (e.g., from the brain) and theinterventional tool can be repositioned so that it is aligned with thenew target area. The interventional probe can be reinserted on atrajectory to intersect with the new target region.

Embodiments of the present invention will now be described in detailbelow with reference to the figures. FIG. 1A illustrates a MRI guidedinterventional placement system 10 that includes a mount 15, a targetingcannula 20, and an elongate probe 30. Although shown as a framelessmount 15, frame-based or other suitable mounting systems may also beused that allow for the adjustability (typically at least two degrees offreedom, including rotational and translational) andcalibration/fixation of the trajectory of the targeting cannula 20and/or probe or tool 30. The mount 15 or components thereof (and/or thepatient) may include fiducial markers that can be detected in an MRI tofacilitate registration of position in an image.

The system 10 may also include a decoupling/tuning circuit 40 thatallows the system to cooperate with an MRI scanner 60. An intermediateMRI scanner interface 50 may be used to allow communication with thescanner 60. The interface 50 may be hardware, software or a combinationof same.

The elongate probe 30 can include at least one electrode 31 on a distaltip portion thereof. The electrode 31 can be a recording and/orstimulating electrode. The electrode 31 can be configured to delivertest voltages for physiologic confirmation of location/efficacy that canbe done by fMRI or by feedback from a non-anesthetized patient. Thus, apatient can be stimulated with the interventional probe 30 (thestimulation may be via a transducer on a distal tip portion of theprobe), to help confirm that the interventional probe is in the correctlocation (i.e., confirm proper location via anatomical as well asprovide physiologic information and feedback). During (and typicallysubstantially immediately after) stimulation from the interventionalprobe, the physician can monitor for a physiologic response from thepatient that can be observed either directly from the patient as aphysical response or via an fMRI-visible response.

The elongate probe 30 can be MRI-visible and may optionally beconfigured to define an MRI antenna. The system 10 can be configured toallow for real-time tracking under MRI, with an SNR imaging improvementin a diameter of at least 5-10 mm proximate the probe 30 or cannula 20.

The targeting cannula 20 can also or alternately be MRI-visible. Thecannula 20 can include an axially extending open lumen 25 that slidablyreceives the probe 30. In some particular embodiments, the cannula 20may optionally comprise a plurality of spaced apart microcoils 21, 22configured to provide data used to provide 3-D dimensional data in MRI3-D space, such as a trajectory, or 3-D spatial coordinates of positionof the cannula 20. As shown, the microcoils 21, 22 can each provide datathat can be correlated to a three-dimensional (X,Y, Z) position in 3-Dspace in the body. The mircocoils 21, 22 can be in communication withthe MRI scanner, and tracking sequences can be generated and data fromone or more of the MRI scanner channels can be used to define positional3-D positional data and a trajectory thereof.

In some particular embodiments, the progress of the cannula 20 and/orinterventional probe 30 may optionally be tracked in substantiallyreal-time as it advances to the target via the coils 21, 22 (similarones of which may also or alternatively be on or in probe 30) and/orantenna 30 a. However, real-time tracking may not be desired in someembodiments.

As shown in FIG. 1B, the cannula 20 can include at least one axiallyextending fluid-filled hollow lumen or closed channel 23 with fluid thatcan generate MRI signal that can be detected by the MRI scanner and/orby an internal MRI antenna incorporated on and/or into the cannula 20that can increase the SNR of the fluid to increase its visibility in anMRI. The fluid may be an aqueous solution (able to resonate at theproton frequency). The cannula 20 can include an axially extending,relatively thin segment, which creates a high contrast MRI image (asegment filled with water or other suitable contrast solution filledsection/lumen). The thickness of the segment may be between about 0.25-4mm (and the segment can have a tubular shape with a diameter or maydefine another cross-sectional shape such as a square section). Thecannula 20 may include MRI imaging coils (MR antenna 30 a) to increasethe signal from the high contrast fluid. The targeting cannula 20 mayfit in the mount directly or in a multilumen insert (as will bediscussed further below).

FIG. 1C illustrates that the targeting cannula 20 can include aplurality of lumens 25. At least some of the lumens 25 can be parallelwith others and extend axially along and through the cannula 20. Theselumens 25 can define parallel tracts to a target in vivo site that canbe selectively used to advance an interventional or localization probe,such as probe 30. The probe 30 can be configured to be selectively inputinto one lumen 25, typically over a distance that is proximate a pivotpoint or zone over a burr hole or other patient access entry location,or serially input into some or all of the lumens 25, thereby providing acorresponding change of trajectory of the access path to the targetsite. Some of the lumens 25 may be MRI-active such as being fluid filledor configured to slidably and releasably receive a fluid filled tube.Some of the lumens 25 may not extend the entire length of the cannula20. FIG. 1C also illustrates that the probe 30 can include one or moreaxially extending side arms 33 that can be sized and configured toreside, at least partially, in a respective lumen 25 to provide MRIsignal and appear in an MRI image. The fluid filled lumens 25 can definetrajectories in MRI 3D space that extend into the body. The cannula 20(and/or multi-lumen insert 300, FIG. 12A) can include fiducialorientation markers that indicate which side lumen is associated withwhich trajectory in an image. The fiducial marker can be defined byshapes, sizes or MRI visible signature shapes or features.

FIGS. 2A-2D illustrate that, in some embodiments, the probe 30 caninclude an external sheath or sleeve 34 that can be configured to snuglyreside about the probe 30 but remain in the body as the probe isslidably removed. The sheath 34 can include a lubricious coating ormaterial or be otherwise configured with a suitable reduced coefficientof friction to allow a snug but slidable fit between the components 30,34. The sheath or sleeve 34 can be a relatively thin biocompatibleelastomeric tubular body with sufficient structural rigidity to maintainthe defined delivery path to the local tissue after removal of the probe30. That is, when the probe 30 is removed, the sheath 34 does notcollapse on itself and does not move from the position as another leadis directed down the sheath to the defined therapeutic location. Thesheath 34 can be slidably advanced over the electrode 31 before theprobe 30 is retracted and removed from at least a distal end portion ofthe sheath 34 and from the targeting cannula 20. As shown in FIG. 2C,the sheath 34 and/or probe 30 can include externally visible indicia 34i, 30 i, of axial extension that can be visually aligned so that aclinician can readily identify the correct movement extension for thesheath to be extended to be substantially precisely placed at thedesired location identified by the electrode 31. The sheath 34 may alsooptionally include a collar or other member that can inhibitover-extension and/or bias the sheath to translate to the desiredextension length (not shown). The sheath 34 typically extends up aboveand out of the frameless mount 15 to allow a clinician ease of access toretrieve (pull) the sheath 34 after the therapy and/or lead placement iscomplete.

In some embodiments, as shown in FIG. 2E, the delivery sheath 34described above as enclosing and housing the multipurpose probe 30 mayalso be used first as a targeting cannula 20″. In this embodiment, thedelivery sheath 34 can be MRI-active and include on-board MRI coils oran MRI antenna 30 a that is built-in and during the targeting/alignmentsteps, a contrast filled tube 134 can be advanced in the delivery sheath34 (before the multi-purpose probe 30). Once the localization and/oralignment steps are completed, the fluid filled tube can be replaced bythe multipurpose probe 30 and the active delivery sheath 34 and themultipurpose probe 30 can be advanced in the tissue. The fluid filledtube 134 may be deflated before removal to facilitate easy of removal.

As also shown in FIG. 1A, the system 10 may optionally be used withand/or also include at least one deep brain stimulation lead 35 with atleast one electrode 36, typically a plurality of electrodes as shown.The lead 35 can be delivered via the cannula 20 after the trajectory andlocation target are defined using the probe 30 and cannula 20. Theelectrodes 31 and 36 are shown in FIG. 1A as generally cylindrical, butother configurations of electrodes may be used. The terms “lead” and“probe” can be used interchangeably to indicate a body used to supportan interventional component such as, for example, the respectiveelectrodes 31, 36. Other numbers of electrodes as well as otherelectrode configurations can be used. For example, the electrodes may betranslatable with respect to the probe body or may be staticallyconfigured thereon. It is contemplated that the electrodes can be sizedand configured to “fit” the desired internal target, which may be arelatively small region, such as less than about 1-3 mm. Typically, asshown in FIG. 1A, the electrodes can be held on a distal portion of theprobe body. A connector 32 on the proximal end portion of the probe body30 can be configured to reside outside of the body during leadplacement. The proximal portion of the probe body can be configured toreleasably connect with a circuit 40 and/or an MRI scanner interface 50via connector 32.

As shown by the broken line, the system 10 may optionally also includeat least one implantable pulse generator 38 that can connect to theimplantable lead 35. The IPG 38 and lead 35 can also comprise MRIcompatible materials and/or components. The frameless mount 15, thetargeting cannula 20, and the probe 30 may be provided as single-usedisposable sterilized components in a medical kit or may bere-sterilized by a clinic between uses.

The probe 30 is typically an elongate flexible probe comprising an outerlayer of elastomeric material, such as a polymer, that extends acrossthe outer surface of the probe body while leaving the electrode(s) 31configured to contact the tissue in position in the body. The probe 30includes at least one conductor lead that electrically connects theelectrode 31 to a remote input or output source, such as the MRI scannerinterface 50. The lead(s) can comprise any suitable material, and may,in some embodiments, comprise a shape memory alloy such as Nitinol.

The targeting cannula 20 can be an MRI-compatible, generally rigidcannula and/or a cannula 20 with increased rigidity relative to theprobe 30, and can be configured to slidably receive at least the distaland intermediate portions of the probe body 30 to guide the distal endportion of the probe 30 into the intrabody target position. The cannula20 can be configured according to a desired body entry location; e.g.,for oral entry, the cannula 20 can be formed into a bite block, nasalcavity or ear plug member, and for non-neural uses, such as placement inthe spinal column, no cannula may be required.

In some embodiments, the targeting cannula 20 and the interventionalprobe 30 can be configured as a unitary tool. In some embodiments, it isalso possible that the targeting cannula 20 and the frameless mount 15(with or without the probe 30) can be a unitary tool such that thecomponents are affixed together.

As for other components noted above, in some embodiments, theimplantable pulse generator 38 as well as the implantable lead 35 mayalso comprise MRI compatible materials to allow placement of the subjectusing the targeting cannula 20.

In some embodiments, as shown for example in FIG. 1B, the probe 30comprises an MRI antenna 30 a that is configured to pick-up MRI signalsin local tissue during an MRI procedure. The MRI antenna 30 a can beconfigured to reside on the distal portion of the probe 30. The MRIantenna 30 a may also optionally be defined by the head mount 15, thetargeting cannula 20 and/or by cooperating components of one or more ofthe head mount 15, cannula 20 and/or the probe 30. The MRI coils builton any of the targeting cannulas 20 herein, or on the mount 15, probes30, sheath 34, multilumen insert 300, alone or in combination, caninclude one or more imaging coils of the following types: loop,solenoid, loopless, dipole antennas, saddle, and birdcage coils. Thesecan be actively tuned and decoupled, inductively coupled, etc.

In some embodiments, the antenna 30 a has a focal length orsignal-receiving length of between about 1-5 cm, and typically isconfigured to have a viewing length to receive MRI signals from localtissue of between about 1-2.5 cm. The MRI antenna 30 a can be formed ascomprising a coaxial and/or triaxial antenna. However, other antennaconfigurations can be used, such as, for example, a whip antenna, a coilantenna, a loopless antenna, and/or a looped antenna. See, e.g., U.S.Pat. Nos. 5,699,801; 5,928,145; 6,263,229; 6,606,513; 6,628,980;6,284,971; 6,675,033; and 6,701,176, the contents of which are herebyincorporated by reference as if recited in full herein. See also U.S.Patent Application Publication Nos. US 2003/0050557; US 2004/0046557;and 2003/0028095, the contents of which are also hereby incorporated byreference as if recited in full herein.

As noted above, the probe 30 can include at least one electrode 31 thatcan operate as a sensing electrode (i.e., for micro-electric recording).The at least one electrode 31 can be more than one electrode and/or theelectrode 31 may be able to both sense and stimulate. For neural uses,different regions in the brain provide different sensed intensities,frequencies and/or pitches (typically readings of between about 1-4microvolts) which are identifiable and can allow a clinician or softwareadditional data to confirm that the probe 30 and/or lead 35 reaches aproper target location.

As will be discussed further below, the mount 15 can be in communicationwith a drive system that can move the mount in desired directions, suchas rotate, adjust pitch or translation, and may advance and/or retractthe cannula 20 and/or probe 30.

FIGS. 3A and 3B illustrates that, in some embodiments, the core of theprobe 30 can be configured to hold at least one (shown as a pluralityof) axially extending conductor(s) 26, typically a respective one foreach electrode 31. In other embodiments, greater or fewer numbers ofconductors than electrodes 31 may be used. As noted above, the probe 30can be a multi-purpose probe. The conductors 26 may be static and heldgenerally encapsulated in a first insulating dielectric layer 61. Inother embodiments, the conductors 26 may be held in the first dielectricmaterial 61 so that they can translate in the axial and/or generallyoutward or transverse directions. Referring again to FIG. 3B, an axiallyextending first shielding layer 62 can surround the first dielectriclayer 61. A second axially extending insulating dielectric layer 63 cansurround the first shielding layer 62. A second axially extendingshielding layer 64 can be electrically connected to the first shieldlayer 62 (that may also be called a primary shield layer) at a proximalend portion thereof. An outer polymeric insulator layer 65 can surroundthe inner layers 61-64 while terminating to typically expose theelectrodes 31 to allow stronger stimulation contact during operation.The conductors 26 extend from the connector 30 to the respectiveelectrode 31. The probe 20 includes an electrical ground 68 and theconnector 30 connects the ground 68 and each electrode 31. As shown, theconnector 30 can include connector prongs (shown as two, but additionalprongs may be used), each having a connection for a respective conductor26 that merges into a respective electrode 31. Where combinations ofelectrodes 31 are used, the conductor 26 can connect to two or moreelectrodes 31 and share a common connector 30 e.

As discussed above, the probe 30 can be configured with an imaging coil30 a to collect MRI signal data for MRI imaging/data collectioncapability and include at least one discrete electrode 31, which can bea directional electrode (directional/volumetric specific electrode) tobe able to controllably generate different stimulation field patterns indifferent directions in situ. Directional electrodes may allow a moreprecise stimulation therapy that can be adjusted based on a patient'sparticular neural circuitry and/or physiology. For additionaldescription of probes and/or components thereof, see, e.g.,PCT/US/2005/026508, the contents of which are hereby incorporated byreference as if recited in full herein.

For example, once the stimulation lead 35 is inserted to a target neuralregion in the brain, the stimulation lead can be activated to use atleast one electrode 36, which provides the desired therapeutic responsewhile minimizing undesired responses. It is contemplated that a moreprecise stimulation of neural tissue that is directionally specific canstimulate only desired neural circuitry and/or tissue. The stimulationmay be output to stimulate target cellular or subcellular matter. Insome embodiments, the stimulation can generally be transmitted withinabout a small stimulation volume. The probe 30 with an MRI antenna 30 acan help position the probe to between about 0.5 mm to about 1.5 mm of atarget neural space, and in other embodiments, between about 0.1-0.5 mm.Once in the target neural space, the stimulation electrode 31 and/orstimulation lead electrode 36 can generate a locationally precise,controlled directional volumetric stimulation that may allow an increasein therapeutic efficacy for different disorders, diseases orimpairments.

FIG. 3C illustrates an electrical schematic of the probe 30 shown inFIGS. 3A and 3B. As shown, the primary or first shield layer 62 axiallyterminates at a distal portion of the probe in advance of the firstelectrode 31. Although shown with a plurality of electrodes 31, a singleelectrode or fewer or greater numbers may be used. The primary shielding62 may be formed into a coil 62 c at a distal portion of the probe 30.In other embodiments, the primary shielding 62 can terminate withoutcoiling (not shown). In yet other embodiments, the shielding 62 may becoiled a distance past one or more electrodes 31, including all the wayforward to the distal end portion (not shown). In some embodiments, arespective conductor 26 can extend to a corresponding electrode 31, withthe longest conductor 26 corresponding to the more distal electrode 31.The conductor(s) 26 may be substantially linear along the length in theprobe body as shown, or may be coiled. If coiled, the coil for theconductor 26 may be at a distal portion, just before the respectiveelectrode 31, which may increase signal (not shown). Each electrode 31is typically in communication with at least one of the insulatedconductors 26. At the proximal end of the probe 20, the conductors 26are connected to a connector 30 so as to be connected to the implantablesignal generator 50 or to the interface circuit 40 during MRI guidedprobe/lead/cable placement. These insulated conductors 26 are typicallycovered with a polymeric insulator sleeve 61, and a conducting materialis cylindrically layered to form the first shielding layer 62 over theinsulator. This shielding 62 is terminated proximal to the electrodesand is not in electrical contact with the conductors or the electrodes.A second insulator/polymeric/dielectric layer 63 further insulates thisshielding to form a multi-core coaxial type cable system with animpedance that is typically between about 10-1000 ohms. The RF chokes 64rf can be integrated or built into the shielding 64 in the form of asecond shielding, which is not continuous and has multiple sections eachλ/4 or less in length.

As shown in FIG. 3C, at the proximal end, each section or segment 64 sis connected to the primary shielding 62, and the distal end may not beelectrically connected to the primary shielding 62, or may be connectedwith a capacitance 164 in between the primary and secondary shielding,62, 64, respectively. A top insulator/polymeric layer 65 can be used toinsulate the probe body 30 b, except for the electrodes 31.

As shown by the axial arrow in FIG. 3C, the antenna 30 a can include anMRI active portion 135 that may extend between a location where theprimary shield 62 terminates and the first electrode 31 ₁. However, asnoted above, other antenna configurations may also be used. As shown,the second shield layer 64 comprises a plurality of axially spaced apartRF chokes 64 rf. The term “RF chokes” refers to an electricalconfiguration formed in a shielding layer and/or internal electrode leadconfiguration that provides an electrical disconnect and/or anelectrical length of less than or equal to λ/4 (from the perspective ofexternal electromagnetic waves) to inhibit the formation and/orpropagation of RF-induced current or standing waves in an AC(alternating current, e.g., diathermy applications) or RF exposureenvironment. The physical length that provides the electrical wavelengthmay vary depending on the materials used in fabricating the probe (suchas dielectric constant) and the magnetic field in which it is used. Insome embodiments, the probe 30 has a physical length that is greaterthan 10 cm, typically between about 20 cm to about 150 cm. In someembodiments, the implantable lead segment 35 can also include RF chokes64 rf formed along target regions or along substantially the entireimplantable length. In the embodiment shown in FIG. 3C, the RF chokes 64rf comprise a plurality of disconnects of the shield 64 and/or discreteelectrically isolated second shield segments. In other embodiments, theRF chokes 64 rf can include a series of axially spaced apart Baluncircuits or other suitable circuit configurations. See, e.g., U.S. Pat.No. 6,284,971, and co-pending U.S. Patent Application Publication,US-2006-0252314-A1, the contents of which are hereby incorporated byreference as if recited in full herein, for additional description ofelectrical leads.

As shown in FIG. 3C, the second shield layer 64 may be coupled to thefirst shielding layer 62 at opposing ends of the segments 64 s. Asshown, one end (typically the proximal end portion) of the disconnectedsegment 64 s is directly coupled to the shielding layer 62 and the otherend (typically the distal end portion) is capacitively coupled to thefirst shielding layer 62. Each segment 64 s may be configured to engagethe first shield layer 62 in the same manner or in an opposing differentelectrical manner (not shown).

FIGS. 4A and 4B illustrate additional exemplary electrical safetycircuits that can be used in combination with other RF safety featuresdescribed herein or alone, for probes 30 or other leads or componentsthat may be exposed to MR systems. Thus, although described as used withrespect to probe 30, the circuit and conductor configurations may beused with other components or devices associated with embodiments of theinvention.

As shown in FIG. 4A, a conductive lead 30 c can include a plurality ofhigh impedance segments 1300 that can be positioned along the length ofthe lead system 30 at regular or irregular intervals, but typically sothat the spacing provides an electrical length of less than about λ/4therebetween. The RF traps 1300 are placed less than about λ/4 apart,where λ is the wavelength in the medium of the operating frequency, toelectrically break the long conductor into multiple sections.

The probe 30 or other member can include multiple high impedancesections or segments 1300 along the length thereof. The high impedancesections or segments can be created by arranging the components of themedical device, i.e., the conductor, etc. as an RF trap. These highimpedance RF traps inhibit the flow of induced RF current (at thefrequency to which the RF trap is tuned) and prevent it from heatingtissue adjacent to the electrodes, thus minimizing or preventing RFinduced tissue damage. Since the physiological and stimulation signalsare at low frequencies (KHz range), the RF trap allows the lowerfrequency signal(s) to go through, trapping only the higher frequenciesof interest to which the traps are tuned.

As shown in FIG. 4A, the conductor 30 c can be in electricalcommunication with the shield at the distal portion of the highimpedance segment 1300 via a tuning capacitor 1340. The high impedancesegment 1300 (e.g., RF trap) can be tuned to a MRI frequency. Thesegment 1300 can also be configured so that the conductor 30 c at theproximal end portion of the segment 1300 p is connected to the shield1325 via a capacitor 1360. One or more of the different high impedancesegments 1300 (shown as 1300 ₁, 1300 ₂, 1300 ₃) may be tuned todifferent MRI frequencies (i.e., 64 MHz and 128 MHz or other standardoperating frequencies of commercial MRI scanners). The impedance of thesegment 1300 can be at least 400 Ohms, typically greater than about 450Ohms. The at least one high impedance segment 1300 can be placed atbetween about 0.1-12 cm from the electrode(s) 31. The lead 30 c can beconfigured with a straight segment 1311 that merges into the coiledsegment 1310.

In operation, the RF trap(s) 1300 with the shield 1325, inductor 1310and tuning capacitor 1340 form a high impedance parallel resonantcircuit at the desired frequency to block RF currents along theconductor. The tuning capacitor can include one or more of a discretecapacitor 1340 and/or stray capacitance between the inductor 1310 andthe shield 1325.

FIG. 4B illustrates that a plurality of conductors (shown as three) 30 c₁, 30 c ₂, 30 c ₃ can be co-wound (see element 1310 c) and reside withina common flexible shield 1325. Each conductor 30 c ₁, 30 c ₂, 30 c ₃ canbe electrically connected to the shield 1325 at a proximal portionthereof, directly or indirectly, such as using a respective capacitor1360 as shown. The capacitor 1360 can provide an RF short. The highimpedance segments 1300 (RF traps) are placed less than a λ/4 apart fromeach other at the desired frequency. The coiled segments of theconductors can define inductors and can each connect a different distalelectrode.

When multiple high impedance segments 1300 (using, for example RF traps)are incorporated over the length of a device such that the distancebetween two adjacent traps is less than one-quarter wavelength, thiseffectively breaks the long conductor into multiple sections, eachshorter than a quarter wavelength. The RF current induced on a conductoris a function of length of the conductor at the RF frequency, and whenthe conductor is shorter than a quarter wavelength, the RF currentinduced is not large enough and may not cause undue RF deposition RFinduced-treating of the tissue.

In some embodiments, as shown for example in FIG. 2D, the probe 30 canbe configured with one or more lumens 39 and exit ports that deliverdesired cellular, biological, and/or drug therapeutics to the targetarea, such as the brain. The probe 30 may also cooperate with and/orincorporate biopsy and/or injection needles and/or ablation means.

Embodiments of the present invention can provide a multi-function MRIsafe lead or probe 30 that can operate at least bimodally: namely,during MRI procedures to obtain MRI signal from local tissue in vivo andto stimulate the target tissue during an MRI procedure. The system 10can be configured for use in any suitable MRI scanner, such as low fieldmagnets (typically about 0.5-1.0 T fields), to a conventional 1.5Tmagnet or higher, such as 2T, 3T or even higher. MRI scanners are wellknown to those of skill in the art and include, but are not limited to,SIEMENS and GE MRI systems.

Configuring a probe 30 to function both as an MRI antenna 30 a (alone orcooperating with other components) and a stimulation and/or recordingprobe 31 may reduce the time needed to place the electrodes in thedesired location, provide for increased accuracy in location and/orreduce the number of times a device is inserted into the brain or othertarget region.

FIG. 5 illustrates a circuit 100 that can provide the bimodal operationof the probe 20. As shown, the circuit 100 includes a splitter circuit102 that is in communication with an electrode stimulation circuit 110that provides the stimulation to the electrode(s) 31. The splittercircuit 102 is also in communication with an RF transmit decouplercircuit 115 that is in communication with an MRI antenna RF receivecircuit 120 and the antenna 30 a on probe 30. Certain or all of thecomponents can be held in the MRI scanner interface 50. In otherembodiments, certain or all of the components of the circuit 100 can beheld in the connector 32.

Generally stated, in some embodiments, the probe 30 can have at leasttwo primary operational modes with different electric transmissionpaths, which are electrically directed using the splitter circuit 102.In operation, during an MRI procedure, an RF excitation pulse istransmitted to a subject. The MRI antenna 30 a is decoupled during RFtransmission, then operative during a receive cycle to receive signalfrom local tissue. The at least one stimulation electrode 31 istypically isolated via the splitter circuit 102 so that only the MRIantenna portion of the probe 30 is active. The MRI interface 50 (FIG. 1)communicates with the MRI scanner and may be configured with asupplemental port to allow the implantable pulse generator or anotherstimulation source to connect thereto, thereby allowing the IPG oranother stimulation source to stimulate the electrodes withoutdecoupling the interface during the placement procedure (confirmingproper placement). In some embodiments, the MRI interface 50 can includea stimulation and/or sensing mode that operates the electrodes.

During MRI-guided clinical implantation of the probe 30, the probe 30can first be used as an MRI antenna to provide high resolution imagingof the target internal anatomy (such as neural tissue) and to locate theposition of the electrodes 31 in the body by obtaining MRI signals and,hence, images that are acquired by the external coils and/or internalMRI antenna. The electrodes 31 can also be used to assess location viaacquiring electrical signals from and/or stimulating the target (neural)anatomy.

FIG. 6 illustrates a different circuit 100 that may be used to providethe different operational modes of the probe 30. FIG. 6 illustrates anMRI antenna receive circuit 135 c that receives the MRI responsivesignal from local tissue and an RF transmit decoupler circuit 135D thatcan decouple the antenna 30 a and the electrodes during RF transmission.The circuit 100 also includes an electrode stimulation circuit 125 thatprovides the stimulation pulses to the electrode(s) 31 and can includean electrode pulse filtering circuit 225 and a recording electrodecircuit 226 used to gather local microelectric signals.

FIG. 7A is a schematic illustration of an exemplary splitter circuit 102that provides different transmission paths for signals operating in theimaging (MR signal) mode and in the sensing microelectrical modeaccording to some embodiments of the present invention. FIG. 7Aillustrates that the circuit 102 can have two sides, 102A, 102B,respectively that substantially overlie each other as shown in FIG. 7Bwith a ground plane therebetween. Side A 102A includes the active pathof the MRI antenna 30 a with matching and tuning components includingdecoupling capacitors 127, conductor connections 126 (to respectiveconductors 26), an input (shown as a BNC input) to the MRI scanner 131,an input to a multi-pin connector for an electrode pulse signal 132 (EPsignal) a PIN diode 128, a matching tuning inductor 129 and amatching/tuning circuit capacitor 130. Side B 102B is the electrodeoperational circuit configured to act as a high pass filter. As shown,the respective electrical transmission paths to the conductors 26include capacitors 138 (shown as 1000 pF capacitors) and 64 MHz RFblocking inductors 139. The blocking inductors 139 can be changed toblock the frequency of the MRI system in use (higher frequencies forhigher field magnets, i.e., for proton imaging, 96 MHz for 2T, 128 MHzfor 3T). It is noted that components of the exemplary circuits are shownwith respect to side A or B for ease of discussion, but certain of thecircuits (or the entire circuit) may reside on a different side thanthat shown (and are not required to be on one side).

In some embodiments, the probe 30 can be placed in the brain, such as inthe subthalamic nucleus or other deep brain target via a burr holeformed in the skull. MR imaging using the probe, 30 can guide anincreased accurate placement in the thalamus or other desired anatomies.Further, the electrical signals from the local tissue can be analyzedand evaluated to determine a final location of the electrodes 31 forstimulation electrodes 36 on lead 35. During this time, the probe can beconnected to the MRI scanner interface 50 that can include amatching-tuning decoupling circuit 40 (FIG. 1A), and a splitter circuitto separate MR signal from the electrical signals generated by the localtarget tissue. Once the probe system is appropriately located in thedesired anatomy, the stimulator can be connected for physiologicalconfirmation of the function. A telescopic system to lengthen or shortenthe lead may be implemented in the proximal section of the probe, sincediameter/profile may not be a significant concern in this region.

As noted above and shown with respect to FIG. 2D, the probe 30 may haveone or more lumens 39 configured to deliver cellular and/or biologicaltherapeutics to the desired neural tissue. The delivery lumens 39 may bemedially located or be formed off-center, such as a channel in asidewall of the device (not shown). The lumens 39 may be configured toreceive an extendable needle that may exit the probe from the distal endor from the sides, proximal, distal, or even through the electrodes toprecisely deliver cellular/biological therapeutics to the desiredanatomy target. This delivery configuration may be a potential way totreat patients, where the cellular/biological therapeutics are deliveredinto the desired anatomy and the neurotransmitter/signal generator pacesthe cells to modify their function. In this way, even if the signalgenerator fails, the cells (stem cells) may differentiate and take overthe function. MRI can be used to monitor the efficacy of the therapy inthe brain.

The stimulation lead 35 and probe 30 can be sized and configured to havesubstantially the same cross-sectional area or one may cooperate with asleeve so as to be held snugly in the sheath 34 and/or targeting cannula20 and/or mount 15. For example, in some embodiments, a non-conductiveelastomeric sleeve (not shown), coating or other configuration can beused to size the stimulation lead 35 and/or probes 30 to snugly fit thecannula 20 as desired. In other embodiments, an insert can be used toadjust the size of the holding port or lumen of the cannula 20 tocorrespond to that of the probe in use (also not shown). The cannula 20and both lead/probes 30, 35, respectively, can be MRI-compatible and mayinclude the RF-safe circuits such as RF chokes, Balun circuits and/orother RF safe configurations. See, e.g., co-pending PCT patentapplication identified by Attorney Docket No. 9450-7WO and U.S. Pat. No.6,284,971, the contents of which are hereby incorporated by reference asif recited in full herein.

In some embodiments, the antenna portion of the probe 30 can define arelatively small MRI receiver length “L,” such as less than about 5 cm,typically between about 1-2.5 cm as noted above. As before, the antenna30 a can be any suitable type and is not limited to a coaxial cable type(including, for example, a dipole or loopless antenna as discussedabove). The probe 30 can be configured to define the antenna 30 a aloneor in combination with other components. For example, in some particularembodiments, the cannula 20 or sheath 34 can form a shielding layer. Insome embodiments, the cannula 20 may comprise a polymer and may includeMRI compatible conductive material, such as Nitonal.

In some embodiments, one or more of the mount 15, a multi-lumen insert300 (FIG. 12A) or cannula 20 can be configured to cooperate with theprobe 30 to define an MRI antenna 30 a. The insert 300, mount 15 and/orcannula 20 can provide a ground and positive signal path. With referenceagain to FIG. 3C, the cannula 20 can provide one or more insulatinglayers 61, 63 or shielding layers 62, 64 with the antenna probe 30providing at least one conductor 26 and potentially one or more of theinsulating layer 61 or shielding layers 62, 64. In particularembodiments, the cannula 20 provides the secondary shield layer 64 andmay include RF chokes 64 rf.

As will be discussed further below, the system 10 can include circuitsand/or modules that can comprise computer program code used toautomatically or semi-automatically carry out operations to stimulate,sense signals in vivo, and/or determine a probe location, a scan planeand localization trajectory(ies) and the like. The module can be incommunication with the probe 30.

The system 10 can be configured to electronically obtain and monitorpatient response data can include electrophysiological input fromsensors held on the body, such as, but not limited to, heart rate, bloodpressure, movement sensors to detect an increase or decrease in patientmovement (to detect shaking or tremors in limbs and the like), fMRIdata, local cellular audio and/or electrical activity (such as using asensing electrode), or other patient response data. Supplementalexternal or internal sensing electrodes may also be positioned on/in thepatient and automatically input to a module to assess whetherdetrimental responses or inadvertent activation of non-target neuralcircuitry may be stimulated. The module may also be configured to acceptinput of patient response data (that may be input by a clinician using acomputer entry screen) to input when detrimental or advantageousresponses are indicated. The patient response data can be input as aninput variable for correlation analysis with other input variables.Where used, the clinician may enter data using a remote or localcomputer, a portable communications device, or other wireless or wireddevice. However, in some embodiments, it may be desired to carry out theevaluation in a substantially automated manner, allowing for apotentially faster stimulation evaluation protocol and patient-specificstimulation determination.

In some embodiments, as shown in FIG. 8, the system 10 can include anautomated Localization Control Circuit 10 c that communicates with anMRI scanner 500 and, optionally, the adjustable mount 15 that resides inthe magnetic field B_(o) of the MRI scanner. The Circuit 10 c can directthe MRI scanner 500 to run certain imaging sequences to identify thescan plane that an elongate member resides in, in 3D MRI space, held inthe mount 15. The system 10 may interface with the MRI scanner andprovide input to drive the scanner 500 to the desired imaging planes, asthey are prescribed on the system (circuit and/or software) as opposedto the scanner 500. Alternatively, the system 10 (circuit and/orsoftware) can provide information to an operator that allows the scanneroperator to select and initiate the imaging planes identified by thesystem 10.

The Circuit 10 c can include a signal processor configured to analyzepixel or voxel data to define the scan plane automatically andrelatively quickly from image data that renders the elongate member withhigher intensity (greater SNR) in a target region of a patient. Thesystem can cooperate with an MRI scanner to identify the scan plane inwhich an elongate targeting marker, such as a sheath 34, insert 300,targeting cannula 20 and/or probe 30 reside. That is, the elongatemember is MRI-visible and configured to have increased SNR relative toother features in the image such that data review of pixels or voxelscan define the location of the member and identify the scan planeassociated therewith.

The Circuit 10 c can determine what adjustments are suitable to move themount 15 to a desired configuration so as to define the targeting ordesired access path trajectory to intersect with target tissue.

FIG. 9 is a block diagram of some operations that may be carried outaccording to embodiments of the invention. As shown, a scan planeassociated with the elongate targeting cannula and/or probe (or otherMRI visible elongate member) residing in 3D MRI space and having a firsttrajectory can be programmatically, typically automatically, determined(block 600), whereby the cannula or probe acts as an MRI detectablemarker. That is, the system 10 can be configured to identify and provide3D coordinates of one or more of the elongate member the target, theburr hole location, etc. in the MRI space. This data can direct whichimaging plane to use to observe the probe and/or access path trajectoryor direct the operator to prescribe the imaging plane on the scanner.

In some embodiments, the scan plane can be determined by electronically(programmatically) reviewing MRI data (typically from at least twoimages taken at oblique angle images) to determine high signal intensitydata associated with the targeting cannula and/or probe (or sheath orother elongate member) (block 605). The signal intensity data may be ofpixels or voxels. In some embodiments, the methods may also oralternatively include electronically (programmatically) reviewing 3Dvolumetric scan data for high signal intensity data to determine thelocation of the target elongate component, i.e., targeting cannulaand/or probe in 3D MRI space (block 610).

In some embodiments, after the scan plane is determined, positionaladjustments (e.g., degrees of rotation, or translation) of the mountholding the cannula and/or probe (or other member) can be electronicallydetermined to generate a second adjusted trajectory to the target site(block 620). The adjustments can be output to a user to allow the userto physically manually change the mount settings using visual indexingor electronic inputs (touch screen or other input means) to allow a userto alter the mount configuration (block 621). Alternatively, the systemcan be fully automated so that the new adjustments can be automaticallyapplied via an automated drive system. That is, a position of an RCMassociated with a head mount can be electronically determined (i.e.,registered in an image) (block 622). A calibrated “current” or “start”position of the head mount can be electronically determined andregistered to a first trajectory in 3D MRI space using transducers,optical encoders and the like. A change in one or more of rotation, tiltor translation of the mount can be programmatically calculated toachieve the desired adjusted trajectory (block 624).

The system 10 can also include an automated MRI scan plane andtrajectory determination module that can define position adjustment datafor the mount 15 (e.g., head mount or other mount type). The adjustmentdata can be output to a clinician to define the frame adjustment inputs(i.e., coordinates) to adjust the trajectory of the frame to the desiredintersection with target tissue. In other embodiments, the adjustmentdata can be used to automatically adjust the frame position on thepatient using automated position or adjustment drive systems to obtainan adjusted trajectory without requiring manual input.

In some embodiments, the system 10 can include a Graphic User Interface(GUI) that allows a clinician to define a desired trajectory and/or endposition on a displayed image, then can electronically convert theorientation/site input data programmatically to generate the frameposition data (not shown). The GUI can include an interactive tool thatallows a clinician to draw, trace or otherwise select and/or identifythe target treatment site and/or access path trajectory. The system 10can then be configured to identify the lumen of choice and/oradjustments to the mount 15 that is most likely to achieve thistrajectory.

In some embodiments, the system 10 includes a user interface that can beconfigured to carry out one or more of the following: (a) electronicallydetermine the location of the targeting cannula/frameless headmount anda trajectory associated therewith; (b) based on the determined locationof the frameless headmount, determine adjustments to the headmount sothat the desired trajectory is achieved, and provide theadjustment/setting information to an operator (or automatically adjustthe settings for automated systems with feedback control); and (c)display MRI images with the projected trajectory and intersectionpoint(s) on that will be followed if the interventional/surgicaldevice/lead is advanced using a defined position of the headmount.

In some embodiments, the location and orientation of one or moreelongate marker(s) (e.g., targeting cannula) in 3D MRI space may beprogrammatically determined by obtaining sagittal and coronal projectionimages, applying high intensity filtering, then using image recognition(such as an image recognition mask) and/or linear regression to findcoordinates of the elongate marker (e.g., cannula) in space.

Alternatively or additionally, the location and orientation of theabove-described elongate marker(s) (e.g., targeting cannula) in 3D MRIspace may be determined by obtaining a 3D volumetric scan, applying highintensity filtering, then using 3D image recognition (such as an imagerecognition mask) and/or linear regression to find coordinates of theelongate marker (e.g., cannula) in space.

More particularly, the location and orientation methods described abovewith respect to the projection images can be carried out as describedbelow. First, sagittal and coronal projection images can be taken of theregion encompassing the marker (e.g., targeting cannula). Next, theseimage arrays are “padded” by adding zeros to the left, right, top, andbottom of the image arrays so that an image recognition mask can beeffectively applied to the edges. These images are processed so thatpoints in the arrays with signal intensity less than a given thresholdare assigned a value of 0, and points above the threshold are given avalue of 1. Then, an image recognition mask A (an a*b array) that tracesout the shape of the marker (e.g., targeting cannula) for a given angleis applied to the images as follows:

-   -   a. Starting at the point (0,0) in the image I (which is an m by        n array) calculate the sum of the values of I(x,y)*A(x,y) for        x:[0,a], y:[0,b].    -   b. Repeat at points (1,0), (2,0), . . . , (m−a,0) in A.    -   c. Repeat in rows 1, 2, . . . , n−b in A.

After these steps are completed for a filtering mask at a given angle,repeat with a mask where the cannula is to be recognized at a differentangle. Repeat the process for suitable angles (such as all reasonablypossible angles). The point where a mask creates the highest summationat a given angle can be recognized as the lower left corner of therectangle defined by the position of the marker (e.g., cannula) inspace, and the angle for that sum is the angle of the marker (e.g.,cannula).

As an alternative to the image mask, the sagittal and coronal image datacan be processed so that points in the arrays with signal intensity lessthan a given threshold are assigned a value of 0, and points above thethreshold are given a value of 1. Next, a linear regression is performedon the points in the image to obtain the line the cannula lies on ineach projection. The first and last points along this line having avalue of 1 define the marker (e.g., cannula) in space.

With respect to the 3D scan methodology, first a 3D scan of the regionencompassing the marker (e.g., targeting cannula.) is taken and/orobtained. Next, the image array is “padded” by adding zeros to the left,right, top, bottom, front, and back of the image arrays so that an imagerecognition mask can be effectively applied to the edges. These imagesare processed so that points in the arrays with signal intensity lessthan a given threshold are assigned a value of 0, and points above thethreshold are given a value of 1. Next, a image recognition mask A (ana*b*c array) that traces out the shape of the targeting cannula for agiven angle is applied to the images as follows:

-   -   a. Starting at the point (0,0,0) in the image I (which is an m        by n by o array) calculate the sum of the values of        I(x,y,z)*A(x,y,z) for x:[0,a], y:[0,b], z:[0,c].    -   b. Repeat at points (1,0,0), (2,0,0), . . . , (m−a,0,0) in A.    -   c. Repeat in rows 1, 2, . . . , n−b in A.    -   d. Repeat in planes 1, 2, . . . , o−c in A.

After these steps are completed for a filtering mask at a given angle,repeat with a mask where the cannula is to be recognized at a differentangle. Repeat for all desired angles (typically for all reasonablypossible angles). The point where a mask created the highest summationat a given angle is recognized as the lower left front corner of therectangular solid defined by the position of the marker (e.g., cannula)in space, and the angle for that sum is the angle of the marker (e.g.,cannula).

As an alternative to the image mask for the 3D scan analysis, theseimages can be processed so that points in the arrays with signalintensity less than a given threshold are assigned a value of 0, andpoints above the threshold are given a value of 1. Next, a linearregression is performed on the points in the image to obtain the linethe marker (e.g., cannula) lies in. The first and last points along thisline having a value of 1 define the marker (e.g., cannula) in space.

If the elongate marker is a targeting cannula that is used with amulti-lumen insert that attaches to the mount 15 and/or if the targetingcannula itself includes multiple lumens, additional information aboutthe path defined by each or more than one lumen can be projected andserially or concurrently displayed on the display, typically a displayat a clinician imaging interface workstation.

FIG. 10A illustrates an example of a frameless mount 15. As shown, themount 15 includes a base plate 190 with an open access lumen 192 thatcan be affixed to a patient, such as to a skull over a burr hole. Themount 15 also includes a port 194 configured to hold the targetingcannula 20 or multi-lumen insert 300 (FIG. 12A), or both (serially). Asshown, the mount 15 also includes upwardly projecting arms 196 that holdthe port 194. The port 194 can slide (translate) forward and rearwardover a curvilinear path defined by the arms 196. The arms 196 cantranslate and rotate with respect to the base 190. In the embodimentshown, the arms 196 attach to a rotatable platform 198 that is attachedto the base 190.

FIGS. 10B-10E illustrate exemplary user adjustment members 198 r, 196 t.The rotation adjustment member 198 r and the translation adjustmentmember 196 t can each comprise at least two members as shown in FIG.10C, to allow for ease of access to the members when mounted and thepatient resides in the bore of a magnet associated with an MRI scanner(and/or accommodate either right or left handed users). The translationadjustment member can adjust pitch (tilt or swivel) while the rotationadjustment member 198 r allows the rotation of the receiving port 194.

In some embodiments, one or both of the adjustment members 198 r, 196 tcan be in communication with non-ferromagnetic flexible drive shafts orcables 198 d, 196 d (FIGS. 10B, 10D) that may extend a suitable distance(e.g., between about 1-4 feet) to allow a clinician to adjust thesettings on the mount 15 without moving the patient and from a positionoutside the bore of the magnet. In other embodiments, the flexible driveshafts can extend a longer distance to an automated control moduleassociated with the Control Circuit 10C (FIG. 8) that can automaticallyadjust the mount trajectory using the input members 198 r, 196 t, basedon an electronic analysis of a target trajectory in MRI data.

In some embodiments, the location/trajectory of the mount 15 can beadjusted manually or via a drive (manual, mechanical, electrical,piezoelectric, pneumatic, hydraulic, etc.) and manually or automaticallyand locked in the final desired orientation. If drive cables 198 d, 196d and electrical connections are used, these may be removable once themount 15 is aligned in the desired position. The mount 15 may havecalibrations (markings) and/or optical encoders, piezoelectric encoders,etc. to determine the settings of the mount and extent of adjustmentcarried out. The sensors or position encoders can provide a feedbackloop that can be used if automated features in positional adjustment areused. Also, once the (head) mount is locked, these encoders can providedata to a monitoring system to monitor the locked position and alert ofany unplanned changes to the headmount settings during a procedure.

FIG. 10B illustrates that the multilumen insert 300 can be integral withthe mount 15. As shown, the insert 300 can attach directly to the mountarms 196. In other embodiments, as shown in FIG. 10E, the insert 300, ifused, can be a separate component or releasably attached to a holdingmember defining the mount port 194.

FIGS. 11A-11F illustrate different configurations that the mount 15 cantake to define a desired access path trajectory extending from the port194 down and through the RCM (pivot zone) 192 p into a patient.

Where the mount 15 is configured as a head mount, the fixture is mountedto the patient's skull, typically threaded or friction fit to a rigid(threaded) burr insert or ring over the burr hole, to provide a stableframe to advance surgical devices, leads, etc. in the brain. Theframeless headmount 15 may be a fixture with two or more degrees offreedom (rotate and translate/swivel) around the RCM. This RCM may bebetween about ±3 cm from the surface of the skull.

The frameless headmount 15 allows the operator to align the access pathtrajectory to an internal target site, such that theinterventional/surgical device/lead, therapy, etc. will be delivered tothe target site following the desired trajectory thorough the cranialtissue. This trajectory goes through the RCM point.

In some embodiments, after a burr hole is drilled and the framelessheadmount is fixed to (in or on) the patient's skull, the first step isto register the position of the headmount, and the trajectory theinterventional/surgical device/lead will follow if advanced through theheadmount. This may be done by multiple ways. For example, the framelessheadmount may have active or passive MRI/CT/ultrasound/optical fiducialmarkers, tracking coils for MRI, which can allow the operator toregister the position of the frameless headmount and the RCM point atany given time based on MRI/CT/ultrasound/optical images. The positionregistration can be determined by analyzing image data obtained in anysuitable ways, such as, but not limited to, projection images in aplurality (2 or more) of substantially orthogonal planes, etc., or 3Dvolumetric scans as described above.

As shown in FIGS. 12A-12E and 13A-13C, the mount 15 (frameless orframed) may hold a multilumen insert 300, through which the cannula 20,the probe 30 and the lead 35 may be advanced. Fiducial markers mayoptionally be incorporated as appropriate on the mount 15 and/or themultilumen insert 300 to facilitate registration of the orientation ofthe lumens 305 of the multilumen insert 300. One or more of the lumens305 may hold a fluid-filled tube (not shown) or include a fluid-filledchannel that makes the lumen MRI visible. Each or some of the lumens305, alone or with elongate inserts, may be in communication or includeMRI imaging coils (not shown). The insert 300 can include fiducialmarkers that allow a clinician to visually denote which lumen providesthe desired trajectory (particularly relevant for the outer lumens 305 p(FIG. 12A) rather than the medial lumen 305 c).

The fiducial markers referenced herein may be provided by trackingcoils, imaging coils or even, for devices having segments with fluidfilled or MRI contrast material, configuring those segments or lumenswith a different MRI visible shape and/or axial starting location (suchas, for example, to be arranged as longer to shorter in a definedperimeter direction), or combinations thereof.

FIG. 14 illustrates a targeting cannula 20 with an open through lumen 25that is sized and configured to allow a probe 30 (typically with anexternal sheath 34, FIG. 2C) to slidably advance therethrough. Thiscannula 20 may reside in the port 194 without the use of a multi-lumeninsert 300 (e.g., directly or with a fitting sleeve or collar, and thelike). As shown, the cannula 20 can also include at least one closedaxially extending fluid-filled hollow lumen 23 that surrounds the lumen25. The closed fluid lumen 23 can include at least one fluid (typicallyliquid) fill port 23 p that can be used to inflate the lumen 23 before,during and/or after the lumen 23 is placed in the cannula 20. The fluidlumen 23 can be defined by a tubular elastomeric body or may be definedby a channel formed in the cannula 20. The cannula 20 can also includeone or more grooves 27 to hold an MRI imaging coil. As also shown, thecannula 20 can include at least one substantially spherical fluid-filledend portion 20 s ₁ that may reside a distance of between about 5-15 cmabove the RCM point. The cannula 20 may also include a secondfluid-filled substantially spherical end portion 20 s ₂ typicallyresiding proximate the RCM point. The spherical end portions 20 s ₁, 20s ₂ may be a part of the lumen 23 or may be discrete and separate fromthe lumen 23.

In some embodiments, the MRI coil can reside on the outside of thecannula 20, and may be a loop MRI coil. The MRI coil can enhance the MRIsignal in the fluid, thereby allowing the operator to visualize thefluid filled sections very clearly. If required, another fluid filledtube may be inserted in the through lumen during the primaryregistration and alignment steps. Once the alignment is done, this tubeis removed and replaced with a multipurpose probe 30 with deliverysheath 34.

In some embodiments, the targeting cannula 20, the multipurpose probe 30and/or delivery sheath 34 can be used to provide additional signal fromthe contrast filled fluid in the targeting cannula 20. This may be usedin place of the MRI coil built on the outer sides of the targetingcannula shown in FIG. 14. It is also noted that, different designs canbe incorporated so that the probe lumen of the cannula 20 is atlocations other than that at the central trajectory, i.e., it may beparallel to the central trajectory or at controlled angle to the centraltrajectory.

FIG. 15A illustrates a targeting cannula 20 that is configured to residein a lumen 305 of the insert 300. This targeting cannula 20 can includeaxially spaced apart, substantially spherical fluid-filled segments 20 s₁, 20 s ₂. In this embodiment, the segments may reside above the lumen305. A fluid-filled lower leg 201 can reside in the lumen 305 and extendto the RCM point 192 p. The fluid can comprise an MRI contrast-enhancingliquid that can be used to define the trajectory of the mount 15 whenresiding in a lumen 305. FIG. 15B illustrates that the targeting cannula20 can include at least one side arm 20 a that can reside in a differentlumen 305 of the insert 300. The side arm 20 a can also include a fluidfilled channel and may optionally include axially spaced apartsubstantially spherical segments. The targeting cannula (contrast mediumfilled) side arm 20 a can provide data that can allow identification ofa precise orientation of the multilumen insert 300.

In the embodiments shown in FIGS. 15A and 15B, the fluid/contrast filledsegments may be relatively thin, such as between about 0.5 mm to about 4mm, typically between about 1 mm to about 3 mm. The segments candelineate the trajectory the interventional device 35 and multipurposeprobe 30 (with delivery sheath 34) will take with the alignment of thehead mount 15. The contrast-filled spherical sections and the straightthin contrast-filled sections of the targeting cannula may provide theimaging signature that can be used for finding the location of thetargeting cannula in the 3D MRI space and provide visual confirmation ofthe trajectory of the device in the tissue. The targeting cannula 20 canhave one or more MRI coils (loop, loopless, solenoid, etc. incorporatedin the design). Also, tracking coils can be optionally incorporated atvarious sections of the targeting cannula to provide 3D locationinformation in MRI space.

FIGS. 16A and 16B illustrate that, where a multi-lumen insert 300 isused, images can be displayed with lines that indicate the trajectory300 t ₁-300 t ₄ (where four lumens are used) followed by each lumen 305of the multilumen insert from the lumen 305 to the target site 1000 t.FIG. 16A corresponds to projections in an oblique coronal/sagittal imagewhile FIG. 16B illustrates the corresponding end points of the lines inan axial/oblique scan. The targeting cannula 20 may be modified as shownin FIG. 15 and/or fiducial markers may be incorporated on themulti-lumen insert 300 and/or mount 15.

FIGS. 17A-17C illustrate steps associated with a typical surgicalprocedure.

1—Place the patient in an MR scanner and obtain MR images of thepatient's head 1000 that visualize the patient's skull, brain, fiducialmarkers 1005 and ROI (region of interest or target therapeutic site).The MR images can include volumetric high-resolution images of thebrain.2—To identify the target ROI, certain known anatomical landmarks can beused, i.e., reference to the AC, PC and MCP points (brain atlases givethe location of different anatomies in the brain with respect to thesepoint) and other anatomical landmarks.3—The location of the burr hole may optionally be determined manually byplacing fiducial markers on the surface of the head or programmaticallyby projecting the location in an image.4—Image in the planned plane of trajectory 1010 and confirm that thetrajectory is viable, i.e., that no complications with anatomicallysensitive areas should occur.5—Optically or manually mark one or more desired locations to drill theburr hole.6—Drill the burr or patient access hole.7—Fix the burr hole ring (where used).

As shown in FIGS. 18A-18E, the following sequence can then be carriedout.

8—Fix the Frameless or frame based head mount.9—Fit the targeting cannula.10—Obtain localization scan to determine/register the location of thetargeting cannula, in direct orientation of the headmount.11—Electronically derive the settings to which the headmount should beadjusted so that the targeting cannula is in the desired trajectoryplane.12—Confirm this by imaging in one or more planes orthogonal to thedesired trajectory plane.13A—If the targeting cannula is so configured (as shown in FIGS. 18D and18E) advance the multipurpose probe and delivery sheath through thetargeting cannula.13B—If the targeting cannula will not allow that; remove the targetingcannula and use the central lumen of the multi-lumen insert—advance themultipurpose probe and delivery sheath in the central lumen of themultilumen insert. Also, the targeting cannula can be configured to fitin the central lumen of the multilumen insert.14—Advance the multipurpose probe and delivery sheath, when imaging inthe trajectory plane, monitoring that the multipurpose probe is in thatimaging plane and it will reach the target accurately.15—On positioning the multipurpose probe in the target site, obtainhigh-resolution images of the anatomy, deliver a stimulation pulse, andoptionally measure EEG signal with the multipurpose probe.16—If multipurpose probe and delivery sheath are at the desired target,leave the sheath in place and remove the multipurpose probe; this sheathwill now act as the delivery cannula for the implantable lead.17—If the multipurpose probe and delivery sheath are not at thedesired/optimal location, decide where the multipurpose probe anddelivery sheath need to be. Adjust the headmount accordingly or useanother appropriate lumen of the multi-lumen insert and readvance themultipurpose probe and delivery sheath.18—Once the multipurpose probe and delivery sheath are at the desiredlocation, remove the multipurpose probe and leave the delivery sheath inplace.19—Advance the lead to the target location using the sheath as a guide.20—Confirm the location of the lead by reviewing an image, acousticrecording and/or stimulation.21—Remove the sheath, leaving the lead in place.

It is contemplated that embodiments of the invention can provide anintegrated system that may allow the physician to place theinterventional device/leads accurately and in short duration of time. Insome embodiments, once the burr hole is drilled, and the frameless headmount is fixed to the skull; the head mount is oriented such that theinterventional device advanced using the frameless headmount follows thedesired trajectory and reaches the target as planned in preoperativesetup imaging plans. As described herein, the system 10 can employhardware and software components to facilitate an automated orsemiautomated operation to carry out this objective.

In some embodiments, the system 10 can include one or more softwaremodules that can automate or carry out aspects of the invention, asshown for example, in FIGS. 19 and 20.

The modules can include data processing systems and computer programproducts in accordance with embodiments of the present invention. Thedata processing systems may be incorporated in a digital signalprocessor in any suitable device. The processor 410 communicates withthe memory 414 via an address/data bus 448. The processor 410 can be anycommercially available or custom microprocessor. The memory 414 isrepresentative of the overall hierarchy of memory devices containing thesoftware and data used to implement the functionality of the dataprocessing system. The memory 414 can include, but is not limited to,the following types of devices: cache, ROM, PROM, EPROM, EEPROM, flashmemory, SRAM, and DRAM.

As shown in FIGS. 19 and 20, the memory 414 may include severalcategories of software and data used in the data processing system: theoperating system 452; the application programs 454; the input/output(I/O) device drivers 458; and data 456. FIG. 19 illustrates the MRIAntenna operation or Electrode Operation Module 450 and FIG. 20illustrates the automated MRI scan plane determination module 453 (withoptional mount setting/adjustment module).

As will be appreciated by those of skill in the art, the operatingsystems 452 may be any operating system suitable for use with a dataprocessing system, such as OS/2, AIX, DOS, OS/390 or System390 fromInternational Business Machines Corporation, Armonk, N.Y., Windows CE,Windows NT, Windows95, Windows98, Windows2000 or other Windows versionsfrom Microsoft Corporation, Redmond, Wash., Unix or Linux or FreeBSD,Palm OS from Palm, Inc., Mac OS from Apple Computer, LabView, orproprietary operating systems. The I/O device drivers 458 typicallyinclude software routines accessed through the operating system 452 bythe application programs 454 to communicate with devices such as I/Odata port(s), data storage 456 and certain memory 414 components. Theapplication programs 454 are illustrative of the programs that implementthe various features of the data processing system and can include atleast one application, which supports operations according toembodiments of the present invention. Finally, the data 456 representsthe static and dynamic data used by the application programs 454, theoperating system 452, the I/O device drivers 458, and other softwareprograms that may reside in the memory 414.

While the present invention is illustrated, for example, with referenceto the Modules 450, 453 being an application program in FIGS. 19, 20, aswill be appreciated by those of skill in the art, other configurationsmay also be utilized while still benefiting from the teachings of thepresent invention. For example, the Modules 450, 453 and/or may also beincorporated into the operating system 452, the I/O device drivers 458or other such logical division of the data processing system. Thus, thepresent invention should not be construed as limited to theconfiguration of FIGS. 19 and 20 which are intended to encompass anyconfiguration capable of carrying out the operations described herein.Further, one or more of modules, i.e., Module 450, 453 can communicatewith or be incorporated into other components, such as an MRI scanner500 or MRI scanner interface.

The I/O data port can be used to transfer information between the dataprocessing system, the MRI scanner, a display associated with aclinician workstation, the mount, cannula, and the probe (such as, forexample MRI imaging data from the MRI imaging coils) and the stimulationlead and another computer system or a network (e.g., the Internet) or toother devices controlled by the processor. These components may beconventional components such as those used in many conventional dataprocessing systems, which may be configured in accordance with thepresent invention to operate as described herein.

With respect to certain embodiments, the computer-readable program codecan include computer readable program code that controllably engages afirst or second operational mode for a MRI compatible stimulation probewith at least one electrode and an MRI antenna. The first operationalmode having a first transmission path connecting the MRI antenna with anMRI scanner and decoupling the electrodes during MRI operation and thesecond operational mode having a second transmission path connecting theelectrodes with a stimulation or recording source during electricalstimulation or recording.

The computer readable program code may be configured to time theselection of the second operational mode to occur proximate in time butafter an MRI signal acquisition by the MRI antenna in the firstoperational mode. The computer readable program code may be configuredto obtain microrecordings of local tissue in substantially real timeproximate in time to an MRI signal acquisition by the MRI antenna in thefirst operational mode. The computer readable program code may beconfigured to obtain a plurality of MRI signals of local neural tissueproximate the MRI antenna in substantially real time, and then obtain aplurality of microrecordings of the local neural tissue to allow aclinician to track placement of the probe using both MRI data and audiodata.

The flowcharts and block diagrams of certain of the figures hereinillustrate the architecture, functionality, and operation of possibleimplementations of the present invention. In this regard, each block inthe flow charts or block diagrams represents a module, segment, orportion of code, which comprises one or more executable instructions forimplementing the specified logical function(s). It should also be notedthat in some alternative implementations, the functions noted in theblocks may occur out of the order noted in the figures. For example, twoblocks shown in succession may in fact be executed substantiallyconcurrently or the blocks may sometimes be executed in the reverseorder, depending upon the functionality involved.

The documents incorporated by reference are done so to describe thestate of the art but are not to be used to narrow the interpretation ofthe terms or components in the claims.

In the drawings and specification, there have been disclosed embodimentsof the invention and, although specific terms are employed, they areused in a generic and descriptive sense only and not for purposes oflimitation, the scope of the invention being set forth in the followingclaims. Thus, the foregoing is illustrative of the present invention andis not to be construed as limiting thereof. Although a few exemplaryembodiments of this invention have been described, those skilled in theart will readily appreciate that many modifications are possible in theexemplary embodiments without materially departing from the novelteachings and advantages of this invention. Accordingly, all suchmodifications are intended to be included within the scope of thisinvention as defined in the claims. In the claims, means-plus-functionclauses, where used, are intended to cover the structures describedherein as performing the recited function and not only structuralequivalents but also equivalent structures. Therefore, it is to beunderstood that the foregoing is illustrative of the present inventionand is not to be construed as limited to the specific embodimentsdisclosed, and that modifications to the disclosed embodiments, as wellas other embodiments, are intended to be included within the scope ofthe appended claims. The invention is defined by the following claims,with equivalents of the claims to be included therein.

1. (canceled)
 2. A localization and/or guidance system for facilitatingplacement of an interventional device in vivo, comprising: a base plateadapted to be affixed to a skull of a patient; and a mount attached tothe base plate, the mount comprising a port configured to releasablyhold a multi-lumen member, wherein the multi-lumen member comprises aplurality of longitudinally extending lumens with image contrast fluid.3. The system of claim 2, further comprising a pair of arcuate laterallyspaced apart arms that hold the mount therebetween and above the baseplate.
 4. The system of claim 2, wherein the mount is slidably supportedby the arms to thereby allow the mount to slidably travel forward andrearward over a curvilinear path defined by the arms.
 5. The system ofclaim 2, wherein the plurality of longitudinally extending lumens have acommon length and are closed channels with the contrast fluid.
 6. Thesystem of claim 2, wherein the plurality of longitudinally extendinglumens comprise five lumens.
 7. The system of claim 2, wherein theplurality of longitudinally extending lumens comprise a center lumenwith adjacent lumens residing spaced apart about the center lumen. 8.The system of claim 2, wherein the mount is configured to serially andinterchangeably hold an elongate guide and the multi-lumen member. 9.The system of claim 8, wherein the elongate guide comprises alongitudinally extending through channel that can align with a patientaccess aperture of the base for slidably receiving an intrabody device.10. The system of claim 2, wherein the base defines a patient accessaperture, wherein the system comprises only a single pair of spacedapart upwardly extending arcuate arms attached to the base, wherein thearms are attached to the base by front and back leg portions that, whenviewed from a lateral direction, extend radially outward and upward fromthe base so as to rise up a distance from the base before merging intothe arcuate arms, and wherein, when viewed from the lateral direction,the front and back leg portions define an open space therebetween tothereby provide a side viewing window, wherein the side viewing windowand the base cooperate to define an open path to the patient accessaperture to allow a user to view the patient access aperture and therebya patient access entry location of the patient, through the side viewingwindow.
 11. The system of claim 8, wherein the elongate guide comprisesan elongate body with an internal wall surrounding the longitudinallyextending open channel, wherein a longitudinally extending fluid filledlumen extends adjacent the open channel over at least a major portion ofa length of the elongate body to merge into a substantially sphericallower end portion, and wherein that the open channel extends through acenter of the substantially spherical lower end portion.
 12. The systemof claim 2, further comprising an electronic in vivo access pathtrajectory determination circuit, the circuit comprising anon-transitory computer readable storage medium having computer readableprogram code embodied in the medium, the computer-readable program codecomprising: computer readable program code configured to electronicallydetermine coordinates of a position in 3-D image space using themulti-lumen member of the system.
 13. A localization and/or guidancesystem for facilitating placement of an interventional device in vivo,comprising: a base plate adapted to be affixed to a skull of a patient;and a mount attached to the base plate, the mount comprising a portconfigured to releasably serially and interchangeably hold (a) amulti-lumen member, wherein the multi-lumen member comprises a pluralityof longitudinally extending lumens with contMRI-visible fluid and (b) anelongate guide, wherein the elongate guide comprises a longitudinallyextending through channel that can align with a patient access apertureof the base for slidably receiving an intrabody device.
 14. The systemof claim 13, wherein the mount is slidably supported by the arms tothereby allow the mount to slidably travel forward and rearward over acurvilinear path defined by the arms.
 15. The system of claim 13,wherein the plurality of longitudinally extending lumens have a commonlength and are closed channels with the contrast fluid.
 16. The systemof claim 13, wherein the plurality of longitudinally extending lumenscomprise five lumens.
 17. The system of claim 13, wherein the pluralityof longitudinally extending lumens comprise a center lumen and aplurality of adjacent lumens, the adjacent lumens residing radiallyoutward from and spaced apart about the center lumen.